Secukinumab in patients with psoriatic arthritis and axial ...
[Pages:16]Ann Rheum Dis: first published as 10.1136/annrheumdis-2020-218808 on 17 December 2020. Downloaded from on October 8, 2022 by guest. Protected by copyright.
Psoriatic arthritis
CLINICAL SCIENCE
Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial
Xenofon Baraliakos,1 Laure Gossec ,2,3 Effie Pournara,4 Slawomir Jeka,5 Antonio Mera-Varela ,6 Salvatore D'Angelo ,7 Barbara Schulz,4 Michael Rissler,4 Kriti Nagar,8 Chiara Perella,4 Laura C Coates 9
Handling editor Josef S Smolen
Additional material is published online only. To view, please visit the journal online (http://d x.doi.o rg/10.1136/ annrheumdis-2020-218808).
For numbered affiliations see end of article.
Correspondence to Professor Xenofon Baraliakos, Rheumazentrum Ruhrgebiet, Ruhr-University Bochum, Claudiusstr. 45, 44649 Herne, Nordrhein-Westfalen, Germany; X enofon.Baraliakos@ elisabethgruppe.de
Received 6 August 2020 Revised 30 November 2020 Accepted 1 December 2020
ABSTRACT Objectives MAXIMISE (Managing AXIal Manifestations in psorIatic arthritis with SEcukinumab) trial was designed to evaluate the efficacy of secukinumab in the management of axial manifestations of psoriatic arthritis (PsA). Methods This phase 3b, double-blind, placebo- controlled, multi-centre 52-week trial included patients (18 years) diagnosed with PsA and classified by ClASsification criteria for Psoriatic Arthritis (CASPAR) criteria, with spinal pain Visual Analogue Score 40/100 and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score 4 despite use of at least two non- steroidal anti-inflammatory drugs (NSAIDs). Patients were randomised (1:1:1) to secukinumab 300 mg, secukinumab 150 mg or placebo weekly for 4 weeks and every 4 weeks thereafter. At week 12, placebo patients were re-randomised to secukinumab 300/150 mg. Primary endpoint was ASAS20 (Assessment of SpondyloArthritis international Society) response with secukinumab 300 mg at week 12. Results Patients were randomly assigned; 167 to secukinumab 300 mg, 165 to secukinumab 150 mg and 166 to placebo. Secukinumab 300 mg and 150 mg significantly improved ASAS20 response versus placebo at week 12 (63% and 66% vs 31% placebo). The OR (95% CI) comparing secukinumab 300 mg and 150 mg versus placebo, using a logistic regression model after multiple imputation, was 3.8 (2.4 and 6.1) and 4.4 (2.7 and 7.0; p ................
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